Volume Restoration of Plantar Pad With a Hyaluronic Acid Dermal Filler in Metatarsalgia

Not Applicable

Completed

• Conditions: Metatarsalgia

• Registration Number: NCT02369380
• Lead Sponsor: Galderma R&D

Brief Summary

Aim of this study is to evaluate the decrease of plantar pain of forefeet due to restoration of plantar pad tissue density and of cushioning function with an hyaluronic acid dermal filler as mechanical-supplementation in subjects with metatarsalgia further use of high heel shoes

Detailed Description

This will be an open and single center study. There will be 4 study visits in total for each subject. Each subject will participate for a period of maximum 6 months.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-12-09
• Study First Submitted QC: 2015-02-17
• Study First Posted: 2015-02-23
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-09
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

• Female subject aged 30 years or older,
• Subject with pain sensation under metatarsal heads, further to use of high heels shoes at any moment of the day whatever the onset time,
• Subject with no previous injections under the metatarsal heads of forefeet.

Exclusion Criteria

• Subject with a personal history of allergic/anaphylactic reactions including hypersensitivity to crossed-linked hyaluronic acid and to Lidocaine or amide local anesthetics
• Subject with cutaneous infection on either foot or with history of autoimmune diseases or auto-inflammatory diseases,
• Subject who wishes to wear orthotic supports (shock-absorbing insoles or arch supports, etc...).
• Subject with history of bleeding disorders or or erysipelas of the lower limbs,
• Subject with chronic inflammatory pain of the feet due to other non-mechanical causes, such as plantar fasciitis, arthritis, gout, Morton's neuroma.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pain assessment (Time to onset of pain (TInitial) (in hours)	Subject questioning at baseline after injections and change from baseline 1 month after baseline	Time to onset of pain (TInitial) (in hours): duration between beginning of wearing high heel shoes and first pain sensations
Pain assessment (Time to maximum pain tolerance (TEnd)	Subject questioning at baseline after injections and change from baseline 1 month after baseline	(in hours): duration between first pain sensations and the maximal pain tolerance (removing shoes).

Secondary Outcome Measures

Name	Time	Method
Podiatric criteria	Change from baseline 6 months after baseline	Baro Podometric static examinations assessed by podiatrist at Baseline, 1 month, 3 months and 6 months after baseline to measure: - Mean pressure under metatarsal heads
Podiatric criteria (Baro Podometric static examinations)	Change from baseline 6 months after baseline	Baro Podometric static examinations assessed by podiatrist at Baseline, 1 month, 3 months and 6 months after baseline to measure: - Maximum mean pressure under metatarsal heads

Trial Locations

Locations (1)

Dr Foumenteze; 🇫🇷 Cannes, France